Disposable blood pressure cuff

ABSTRACT

A disposable blood pressure cuff is made from a composite of a non-stretchable paper component and an elastic thermoplastic material component. The paper component provides the necessary outer circumferential strength for the cuff so that it will not stretch outwardly when it is inflated. The thermoplastic layer provides an inwardly expandable surface for contacting a limb of the patient which the cuff encircles. A tape tab is included to releasably attach the cuff to the patient&#39;s limb. The tab is provided with a visible indicium which indicates the proper degree of overlap of the ends of the cuff when the latter is affixed to the patient&#39;s limb. The cuff may be used by only one patient, and may be discarded when the patient is finished with it. The cuff is provided with a one-piece slip luer fitting which includes a flange disposed within the chamber, and an annular tube projecting through an outer component of the cuff. The slip luer flange is adhered to the outer cuff component, and the annular tube includes a tapered part which is operative to provide a sealed joint with a complementary luer fitting on a blood pressure monitor inflation/deflation line, thereby eliminating the necessity of a separate hose component on the cuff.

This is a continuation of U.S. Ser. No. 08/300,396, filed Sep. 2, 1994,now U.S. Pat. No. 5,511,552.

TECHNICAL FIELD

This invention relates to an inflatable blood pressure cuff and moreparticularly to a cuff which is formed from a composite which includesan outer non-stretchable paper component, and an inner elasticthermoplastic material component which contacts the patient, which cuffmay be discarded and safely disposed of after use by a patient.

BACKGROUND ART

Inflatable blood pressure cuffs are typically composite structuresformed from vinyls, nylon, rubber and typically include a hook and looptype of closure. The various material layers in the cuff are stitched orotherwise bonded together so as to form the inner inflatable bladderpart of the cuff, and the outer constricting part of the cuff. The cuffmust be capable of being inflated on the patient without undergoingundue radial expansion. The aforesaid cuffs are used on the entirepatient population, and are not typically designed for use on only onepatient. These cuffs are relatively expensive and are not intended to bediscarded after use on a particular patient. Cuffs have been designedwhich are intended to be used on only a single patient, but their costhas caused them to be reused on other patients. It would be desirable tohave a sufficiently inexpensive blood pressure cuff that is designed foruse on only one patient, and that can be economically discarded afteruse on the patient.

DISCLOSURE OF THE INVENTION

This invention relates to an inexpensive inflatable blood pressure cuffwhich is intended to be used on only one patient and which may beeconomically discarded and safely disposed of after it has been used.Disposal of the cuff after a single patient's use eliminates the risk ofthe cuff contaminating other patients or health care givers who wouldotherwise also use the cuff. Single patient use is especially importantin cases where the cuff is being used in emergency situations, or isbeing used on patients who have infectious diseases that might betransmitted to others by the cuff.

The cuff of this invention is formed as a composite structure whichincludes an outer paper component for strength, and an inner elasticresinous component for the necessary arterial occluding capability. Thepaper component is formed from an essentially non-stretchable paper suchas paper marketed by James River Corporation under the brand nameRiegel, grades GP23XD, GP23XE, GR23XG or GP25BL, or an equivalentlynon-stretchable paper. The paper component will preferably have innerand outer surfaces which are provided with a thermoplastic materiallayer so as to provide heat-sealable surfaces and/or adhesive-receptivesurfaces on the outer component. The outer paper component will provideenhanced printing capabilities on the outer surface of the cuff.Existing blood pressure cuffs are screen printed, which provides verylimited print quality. The inner portion of the cuff will be formed bythe elastic thermoplastic material. With the conjoined outer papercomponent and inner thermoplastic component, the cuff, when inflated,will not expand outwardly, but it will expand inwardly so as toappropriately occlude a patient's appendage. The cuff will also includea closure member which is preferably an adhesive tape strip attached toone edge of the outer surface of the cuff. The closure strip can beequipped with a visible indicium that provides an indication of theproper degree of overlap of the ends of the cuff when affixed to thepatient.

The cuff of this invention can be fabricated by heat sealing orotherwise securing the edges of the inner elastic and outer constrictingcomponents together so as to form the cuff with an internally flexibleand outwardly constricted inflatable chamber. A male luer fitting willbe provided in the outer component for attachment to aninflation/deflation hose. After patient use, the cuff can be safelyincinerated or recycled without producing any harmful toxins.

It is therefore an object of this invention to provide a disposableinflatable blood pressure cuff which is intended for use by only onepatient.

It is a further object of this invention to provide a cuff of thecharacter described which is inexpensive to fabricate.

It is another object of this invention to provide a cuff of thecharacter described which can be disposed of by incinerating, or can berecycled without producing any harmful toxins.

These and other objects and advantages of the invention will become morereadily apparent from the following detailed description of theinvention when taken in conjunction with the accompanying drawings inwhich:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of an embodiment of the cuff of this invention;

FIG. 2 is a sectional view of the cuff taken along lines 2--2 of FIG. 1;

FIG. 3 is an enlarged fragmented sectional view of the outer componentof the cuff showing the various laminations included therein;

FIG. 4 is a sectional view taken along line 4--4 of FIG. 1 showing analternate way of joining the inner and outer components of the cufftogether;

FIG. 5 is a sectional view similar to FIG. 4 but showing yet another wayof joining the inner and outer components of the cuff together; and

FIG. 6 illustrates the manner of use of the cuff on a patient's arm.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, there is shown in FIGS. 1 and 2 apreferred embodiment of an inflatable blood pressure cuff formed inaccordance with this invention. The cuff is denoted generally by thenumeral 2 and includes an outer component 4 which provides the necessaryappendage constriction strength and has a primary component layer whichis formed from a laminate that includes a layer of non-stretchablepaper. The outer component 4 is sealed at its peripheral edges 6 to aninner elastic component 8 which is formed from an elastic resinousmaterial such as polyethylene, or the like. The outer and innercomponents 4 and 8 combine to form an internal cavity 10 which can beinflated so as to expand the elastic component 8 against the patient'sappendage to occlude blood flow in the appendage sufficiently to enableoscillometric or ausculatory blood pressure measurements to be made in aknown manner. A male luer fitting 12 is fitted into an opening 14 in theouter component 4 and is operable to telescopingly connect directly witha mating luer fitting on an inflation/deflation hose on an automatedblood pressure monitor (not shown) during inflation and deflation of thecuff 2. The cuff-mounted luer fitting 12 eliminates the need for aseparate hose component on the cuff, and the separate luer sub-componentcommonly used in the prior art, since the fitting 12 may be coupleddirectly with the monitor hose mating luer fitting. The luer fitting 12has an integral flange 16 which is bonded to the inner surface 5 of theouter component 4, as will be explained hereinafter. The cuff 2 has aclosure component 18 which extends beyond one edge 20 of the cuff 2 andwhich is adhered to the outer surface of the outer cuff component 4. Theclosure component 18 can advantageously be formed from a strip ofcontact adhesive tape, and may include an indicium 22 such as a visiblestripe which can serve as an indicator for alignment with a series ofindicia 24 on the opposite side of the cuff 2 which indicate arecommended range of cuff overlap for providing proper cuff fittings.The distal edge of the closure 18 can be folded underneath as at 24 (seeFIG. 2) to provide a non-tacky area for manual gripping purposes. Arelease strip (not shown) can also be provided to cover the tackysurface of the closure 18.

Referring now to FIG. 3, there is shown a suitable lamination sequencefor the outer cuff component 4. The outermost layer 26 of the outer cuffcomponent 4 is preferably polypropylene which is applied to theunderlying layer 28, which is the non-stretchable paper, so as toprovide a smooth surface for the closure tape 18 or other closure to beadhered to, as well as protecting any printing on the underlying paperlayer. A polyethylene layer 30 is disposed on the inner surface of thepaper layer 28 and a metallic foil layer 32 (preferably aluminum foil)is heat sealed onto the polyethylene layer 30. The innermost layer 34 ofthe outer cuff component 4 is preferably polyethylene. The polyethylenelayer 34 allows the outer and inner cuff components 4 and 8 to beedge-bonded to each other to form the sealed internal cavity 10 in thecuff 2. The polyethylene layer 34 also allows the luer flange 16 to beheat seal-bonded to the inner surface 5 of the outer cuff component 4.The inner cuff component 8 is preferably polyethylene and it may have apatient-comfort layer on it, such as cotton flocking, foam, or the like,which comfort layer contacts the patient's skin.

Referring now to FIGS. 4 and 5, there are shown several differentvariations in the cuff-wise longitudinal peripheral edge seals betweenthe outer cuff component 4 and the inner cuff component 8. In theembodiment shown in FIG. 4, one edge 3 of the outer cuff component 4 isfolded over and sealed to the adjacent edge of the inner cuff component8, while the opposite edge 6 is formed with a simple face-to-face sealapplication. In the embodiment shown in FIG. 5, both edges of the outercuff component 4 are folded over and sealed to the adjacent edges of theinner cuff component 8. The folded-over versions are operative to roundoff the edges of the cuff.

FIG. 6 shows how the cuff 2 is applied to the arm of a patient, with theclosure tape 18 being overlapped on the cuff 2, and with the luerfitting 12 rendered available for securement to a complementary luerfitting on the monitor inflation/deflation hose.

The aforesaid description of the invention provides information as toone embodiment of the cuff of this invention, however, other cuffconstructions are also contemplated by the invention. For example, theouter layer of the cuff could be formed from the following sequences ofair impermeable layers, as seen from the inside to the outside of thecuff. The following sequences are illustrative of material laminatesequences that could be used to form the cuff of this invention:

a) polyethylene/aluminum foil/polyethylene/paper/polyester;

b) polyethylene/aluminum foil/polyethylene/paper/polyethylene;

c) polyethylene/aluminum foil/polyethylene/paper;

d) polyethylene/paper/polypropylene;

e) polyethylene/paper;

f) "SURLYN"ionomer resin/aluminum foil/polyethylene/paper/polypropylene;

g) "SURLYN"ionomer resin/aluminum foil/polyethylene/paper/polyester;

h) "SURLYN"ionomer resin/aluminum foil/polyethylene/paper/polyethylene;

i) "SURLYN"ionomer resin/aluminum foil/polyethylene/paper;

j) polyethylene/paper/polyester;

k) "SURLYN"ionomer resin/paper/polypropylene;

l) "SURLYN"ionomer resin/paper/polyester;

m) "SURLYN"ionomer resin/paper/polyethylene;

n) polyethylene/paper/polyester/polyethylene;

o) "SURLYN"ionomer resin/paper; and

p) heat-seal coating/paper.

The above listing is intended to be illustrative of possiblecombinations, and is not an exhaustive listing.

"Surlyn" is a trademark of DuPont de Nemours, E. I. & Co. for ionomerresins. Suitable heat-seal coatings include polyethylene,"SURLYN"ionomer resin, polyurethane, ethyl vinyl acetate (EVA), ethylacrylic acid, ethyl methyl acrylic acid, and the like.

The aforesaid layers can be bonded together by heat sealing, radiofrequency bonding, glueing, or the like. Instead of using an adhesivetape closure, the cuff could utilize a hook and loop fastener adhered tothe outer surface of the cuff.

The cuff is primarily sufficiently inexpensive so as to be discardableafter use by a single patient, however, it is sufficiently durable so asto be capable of multiple uses if so required.

Since many changes and variations of the disclosed embodiments of theinvention may be made without departing from the inventive concept, itis not intended to limit the invention otherwise than as required by theappended claims.

What is claimed is:
 1. An inflatable blood pressure cuff comprising:a)an outer air-impervious component which includes an essentiallynon-stretchable paper layer that resists outward expansion when the cuffis inflated; b) an inner elastic resin component which combines withsaid outer component to form an internal expandable chamber, said resincomponent being operable to compress a patient's appendage when saidexpandable chamber is inflated, said inner and outer components havingjoined edges which are operable to seal all edges of said expandablechamber; and c) a fitting which is adapted to be connected to aninflation/deflation hose, said fitting allowing selected inflation anddeflation of the cuff.
 2. The cuff of claim 1 wherein said innercomponent is formed from polyethylene, said polyethylene inner componentincluding peripheral edges which are sealed to corresponding peripheraledges of said outer component to close said chamber.
 3. The cuff ofclaim 2 wherein said peripheral edges on said inner component are sealedto surfaces of said outer component which face said internal chamber. 4.The cuff of claim 2 wherein said peripheral edges on said innercomponent are sealed to surfaces of said outer component which face awayfrom said internal chamber.
 5. The cuff of claim 2 wherein saidperipheral edges on said inner component are sealed to first surfaces ofsaid outer component which face toward said internal chamber, and aresealed to second surfaces of said outer component which face away fromsaid internal chamber.
 6. The cuff of claim 1 further including aclosure adhered to an outer surface of said outer component, saidclosure extending beyond an edge of the cuff to provide means forsecuring the cuff on an appendage of a patient.
 7. The cuff of claim 6wherein said closure is an adhesive tape.
 8. The cuff of claim 7 whereinsaid adhesive tape includes visible indicium for determining a properextent of overlap for the cuff when the latter is applied to thepatient's appendage.
 9. The cuff of claim 1 wherein said outer and innercomponents are formed from materials which can be disposed of byincineration without producing toxic by products.
 10. An inflatableblood pressure cuff which may be used by a single patient and safelydisposed of thereafter, said cuff comprising:a) an inner elastic resincomponent, said inner component being operable to compress a patient'sappendage when said cuff is inflated; b) an outer air-imperviouscomponent which combines with said inner component to form an internalexpandable cuff inflation chamber, said outer component comprising:i) afirst layer of bondable material facing said inflation chamber, saidbondable layer having edges that are sealed to said inner elastic resincomponent to seal said cuff inflation chamber from ambient surroundings;ii) an essentially non-stretchable paper layer secured to and overlyingsaid first layer, said paper layer being operable to resist outwardexpansion when the cuff is inflated; and c) a fitting which is adaptedto be connected to an inflation/deflation hose, said fitting allowingselected inflation and deflation of the cuff.